Biocompatible medical films are most often used in surgical settings as a physical barrier to help separate certain organs from adjacent tissues and medical devices following surgical intervention or blunt dissection to minimize adhesion formation between adjacent tissues. For example, SEPRAFILM®, a product of Genzyme Corporation of Cambridge, Mass., is used in patients undergoing either open or laparoscopic abdominal or pelvic surgeries as an implantable treatment intended to reduce the incidence, extent, and severity of postoperative adhesion formation between different tissues and organs and implantable medical devices, such as soft tissue support membranes and mesh, or combinations of non-absorbable films and meshes.
U.S. Pat. No. 5,017,229 (the “'229 patent”) is directed to a water insoluble, biocompatible gel that includes the reaction product of hyaluronic acid, a polyanionic polysaccharide, and an activating agent. The gel described in the '229 patent can be provided in the form of a tissue to tissue adhesion prevention composition, such as a membrane or composition suitable for incorporation into a syringe. The gel is described as being able to form a film by being cast into a sheet form, extruded, compressed, or allowed to dehydrate in a flat sheet. When modified with polysaccharide, the biodegradable film forms the above-described SEPRAFILM® adhesion-limiting or adhesion barrier product made commercially available as a dehydrated bio-dissolvable single layer sheet.
Many commercially available tissue to tissue adhesion prevention and adhesion barrier film products often can be difficult to handle and apply to the targeted location due to their chemical make up and rapid bio-dissolvable properties. The composition and limited structural strength properties of these bio-dissolvable products result in the material forming the products softening relatively quickly upon exposure to fluids; thus, handling of these barrier film products can be difficult during most open and laparoscopic surgical intervention operations. In addition, many of these films become tacky when exposed to fluid and adhere to an implanted location. When these barrier films break down, they remain in place due to their adhesive properties.
There are, however, commercially available barrier films which do not exhibit adhesive properties when exposed to fluid, and therefore do not stick to the implanted location. In some instances, these films can shift and can bunch or ball up; thereby reducing the effectiveness of these films. For example, after spinal surgery the film can be placed between the spine and soft tissue surrounding the spine to prevent the soft tissue from growing into the spine. If the film shifts to expose the spine to the soft tissue before the spinal area has substantially healed the soft tissue can grow into the spine.
While barrier films can be formed on reinforced devices, such as surgical meshes, to provide additional structure to the barrier films, there may be some instances where the use of an underlying mesh is undesirable. For example, in some instances it may be desirable simply to have a barrier between connective tissues and/or bones to prevent adjacent connective tissues from growing together without providing the additional structure of an underlying mesh.